510(k) K071079

SPECTRA OPTIA APHERESIS SYSTEM, SPECTRA OPTIA EXCHANGE SET, MODEL 61000, 10200 by Gambro Bct, Inc. — Product Code LKN

K071079 is an FDA 510(k) premarket notification submitted by Gambro Bct, Inc. for the device "SPECTRA OPTIA APHERESIS SYSTEM, SPECTRA OPTIA EXCHANGE SET, MODEL 61000, 10200". The FDA issued a decision of Substantially Equivalent on August 2, 2007. The device falls under product code LKN (Separator, Automated, Blood Cell And Plasma, Therapeutic), a Class U device.